Ebola Zaire vaccine (Rx)

Brand and Other Names:Ervebo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • 1mL (single-dose vial)

Immunization Against Ebola Zaire Virus

Indicated for prevention of disease caused by Zaire ebolavirus

1 mL IM once

ACIP recommendations

  • Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following people who:
  1. Are responding to an outbreak of Ebola virus disease; or
  2. Work as healthcare personnel at federally-designated Ebola Treatment Centers (ETCs) in the U.S.; or
  3. Work as laboratorians or other staff at biosafety-level 4 facilities in the U.S.

Dosing Considerations

Limitations of use

  • Duration of protection conferred by vaccine is unknown
  • Does not protect against other species of Ebolavirus or Marburgvirus
  • Effectiveness of vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown

<18 years: Safety and efficacy not established

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Adverse Effects

>10%

Injection site pain (34-69.5%)

Headache (36.9%)

Feverishness (34.3%)

Muscle pain (32.5%)

Fatigue (18.5%)

Joint pain (17.9%)

Injection site swelling (16.5%)

Injection site redness (11.9%)

1-10%

Nausea (8%)

Joint pain/tenderness (7%)

Arthritis (0.8-4.7%)

Rash (3.6-3.8%)

Abnormal sweating (3.2%)

Local reactions (eg, redness, swelling) (1.8%)

Vesicular lesions (1.5%)

<1%

Arthropathy (joint redness/warmth) (0.6%)

Joint swelling (0.4%)

Joint stiffness (0.4%)

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Warnings

Contraindications

Hypersensitivity to any component of the vaccine, including rice protein

Cautions

There were 2 reports of anaphylaxis; monitor for signs and symptoms of hypersensitivity reactions following vaccination; appropriate medical treatment and supervision must be available in case of an anaphylactic event following administration

Vaccination may not protect all individuals; vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission

Safety and effectiveness have not been assessed in immunocompromised individuals; weigh the risk of vaccination in immunocompromised individuals against the risk of disease due to Zaire ebolavirus

Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility

Drug interaction overview

  • Interference with laboratory tests
    • Following vaccination, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens
    • GP-based testing may have limited diagnostic value during period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine
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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women, and human data available from clinical trials are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy

Consider the woman’s risk of exposure to Zaire ebolavirus before vaccination

Clinical considerations

  • Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus
  • Majority of such pregnancies end in miscarriage or stillbirth
  • In pregnancies where live birth does occur, neonates generally do not survive
  • Potential for transmission of the vaccine virus from mother to the fetus/neonate is unknown

Lactation

Human data are not available to assess the effects on milk production, its presence in breast milk, or its effects on the breastfed child

Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition

For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant vesicular stomatitis virus-Zaire ebolavirus (rVSV-ZEBOV; V920) is a replication-competent vaccine

Genetically engineered to express a glycoprotein from the Zaire ebolavirus to provoke a neutralizing immune response to the Ebola virus

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Administration

IM Preparation

Thaw vial at room temperature until no visible ice is present; do not thaw vial in a refrigerator

Gently invert vial several times

Visually inspect for particulate matter and discoloration before use, vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible

Use the vaccine immediately after thawing

Withdraw 1-mL dose from vial using a sterile needle and sterile syringe

IM Administration

Administer a 1-mL dose IM, preferably in the deltoid area of the nondominant arm

Discard unused portion

Storage

Unopened vials: Freeze at -80 to -60ºC (-112 to -76ºF) in the original carton to protect from light; do not thaw the vial in a refrigerator

Thawed vials: If not used immediately, refrigerate at 2-8ºC (35.6-46.4ºF) for a total time of no more than 2 weeks and at room temperature (up to 25ºC; 77ºF) for a total time of no more than 4 hr

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.